Month: January 2023

Carmot Therapeutics Launches Spin-Off, Kimia Therapeutics, to Focus on Metabolic Disease

01/16/2023

– Spin-off of technology platform to newly-formed Kimia Therapeutics intended to maximize the full potential of Carmot’s metabolic portfolio while enabling Kimia to pursue a broad range of opportunities across oncology, immunology and inflammation – – Encouraging clinical data from CT-388 and CT-868, Carmot’s dual GLP-1/GIP receptor modulators, represent significant opportunity for Carmot to advance…

Read More

ArsenalBio Announces First Patient Dosed in Phase 1 Clinical Trial of AB-1015 in Development as a Treatment for Ovarian Cancer

01/16/2023

Company will provide a business overview including product pipeline during an upcoming presentation on January 10th at the J.P. Morgan 41st Annual Healthcare Conference Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Arsenal Biosciences, Inc. (ArsenalBio), a privately held, clinical stage, programmable cell therapy company engineering advanced CAR T cell therapies for solid tumors,…

Read More

Aligos Therapeutics on Track to Complete Phase 2-Enabling Activities in 2023 for its Clinically Validated THR-ß Drug Candidate for NASH, ALG-055009

01/16/2023

– Final cohort of Phase 1 study projected to be complete in H1 2023 – – Phase 2-enabling GLP toxicology studies projected to be complete in H2 2023 – – Clinical update on all pipeline programs to be presented at the 2023 J.P. Morgan Healthcare Conference on January 12 at 10:30 a.m. PT – Excerpt…

Read More

FDA Approves IND Submission Allowing ABVC BioPharma to Proceed With Clinical Study of ABV-1519 for Treatment of Non-Small Cell Lung Cancer

01/13/2023

Excerpt from the Press Release: FREMONT, CA, Jan. 05, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology today announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation…

Read More

Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis

01/13/2023

As previously reported, resmetirom demonstrated improvements in NASH and liver fibrosis on liver biopsies, the primary endpoints of the MAESTRO-NASH trialA supportive analysis using consensus reads of digitized biopsy images by the central pathologists replicated the positive primary endpoint resultsThese data will be presented at the NASH-TAG Conference on Friday January 6th, 2023 Excerpt from…

Read More

Integral Molecular Reveals Mechanism Underlying Exquisite Specificity of Claudin 6 Therapeutic Antibody Being Developed for Solid Tumors

01/13/2023

Excerpt from the Press Release: PHILADELPHIA–Integral Molecular, the industry leader in antibody discovery for membrane proteins, has published the targeting mechanism enabling best-in-class specificity of its Claudin 6 (CLDN6) antibody CTIM-76 being developed for cancer therapy with Context Therapeutics. CLDN6 is a tumor-specific protein found in multiple solid tumors—including ovarian, endometrial, lung, gastric, and testicular—but…

Read More

Helius Extends its Patient Therapy Access Program (PTAP), Bringing the Benefits of its PoNS® Device to More People with Multiple Sclerosis

01/12/2023

Excerpt from the Press Release: PTAP Lowers the Cost of PoNS Therapy™ for Qualified Americans NEWTOWN, Pa., Jan. 05, 2023 (GLOBE NEWSWIRE) — Helius Medical Technologies (NASDAQ: HSDT) today announced the extension of a program that puts the company’s Portable Neuromodulation Stimulator (PoNS®) into the hands of qualified Americans with multiple sclerosis (MS) at a…

Read More

Sionna Therapeutics Announces Advancement of Cystic Fibrosis Pipeline Programs and Presentation at J.P. Morgan 41st Annual Healthcare Conference

01/12/2023

– Enrolling Phase 1 study of lead NBD1 modulator, SION-638, following IND clearance from the FDA; data expected in the second half of 2023 – – SION-109, targeting complementary mechanism ICL4, on-track for IND submission in the first half of 2023 – – Three additional development candidates nominated for progression including two Series 2 NBD1…

Read More

Orchard Therapeutics Announces U.S. FDA Clearance of IND Application for OTL-203 in MPS-IH

01/12/2023

Global registrational trial expected to commence in the second half of 2023 Excerpt from the Press Release: BOSTON and LONDON, Jan. 05, 2023 (GLOBE NEWSWIRE) — Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OTL-203, a…

Read More

Homology Medicines Provides Update on pheEDIT and juMPStart Clinical Trials and Announces Expected 2023 Milestones, Including Initial Data Read-Outs from Both Programs

01/11/2023

Strong Cash Position with Runway into Fourth Quarter 2024 Non-Clinical Data on Immunosuppression Regimen Supportive of Clinical Programs Preclinical Data from HMI-103 Gene Editing Program Utilizing a Unique Mechanism of Action Demonstrated Significantly Increased Potency in PKU Model Excerpt from the Press Release: EDFORD, Mass., Jan. 04, 2023 (GLOBE NEWSWIRE) — Homology Medicines, Inc. (Nasdaq:…

Read More